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CTCAE v4.0 Toxicity Codes Category ECOG Code CTCAE v4.0 Term Blood and lymphatic system disorders BL101 Anemia Blood and lymphatic system disorders BL999 Blood and lymphatic system disorders - Other, specify Blood and lymphatic system disorders BL102 Bone marrow hypocellular Blood and lymphatic system disorders BL103 Disseminated intravascular coagulation Blood and lymphatic system disorders BL104 Febrile neutropenia Blood and lymphatic system disorders BL105 Hemolysis Blood and lymphatic system disorders BL106 Hemolytic uremic syndrome Blood and lymphatic system disorders BL107 Leukocytosis Blood and lymphatic system disorders BL108 Lymph node pain Blood and lymphatic system disorders BL109 Spleen disorder Blood and lymphatic system disorders BL110 Thrombotic thrombocytopenic purpura Cardiac disorders CA101 Acute coronary syndrome Cardiac disorders CA102 Aortic valve disease Cardiac disorders CA103 Asystole Cardiac disorders CA104 Atrial fibrillation Cardiac disorders CA105 Atrial flutter Cardiac disorders CA106 Atrioventricular block complete Cardiac disorders CA107 Atrioventricular block first degree Cardiac disorders CA108 Cardiac arrest Cardiac disorders CA999 Cardiac disorders - Other, specify Cardiac disorders CA109 Chest pain - cardiac Cardiac disorders CA110 Conduction disorder Cardiac disorders CA111 Constrictive pericarditis Cardiac disorders CA112 Heart failure Cardiac disorders CA113 Left ventricular systolic dysfunction Cardiac disorders CA114 Mitral valve disease Cardiac disorders CA115 Mobitz (type) II atrioventricular block Cardiac disorders CA116 Mobitz type I Cardiac disorders CA117 Myocardial infarction Cardiac disorders CA118 Myocarditis Cardiac disorders CA119 Palpitations Cardiac disorders CA120 Paroxysmal atrial tachycardia Cardiac disorders CA121 Pericardial effusion Cardiac disorders CA122 Pericardial tamponade Cardiac disorders CA123 Pericarditis Cardiac disorders CA124 Pulmonary valve disease Cardiac disorders CA125 Restrictive cardiomyopathy Cardiac disorders CA126 Right ventricular dysfunction Cardiac disorders CA127 Sick sinus syndrome Cardiac disorders CA128 Sinus bradycardia Cardiac disorders CA129 Sinus tachycardia Cardiac disorders CA130 Supraventricular tachycardia Cardiac disorders CA131 Tricuspid valve disease Cardiac disorders CA132 Ventricular arrhythmia Cardiac disorders CA133 Ventricular fibrillation Cardiac disorders CA134 Ventricular tachycardia Cardiac disorders CA135 Wolff-Parkinson-White syndrome Congenital, familial and genetic disorders FG999 Congenital, familial and genetic disorders - Other, specify Page 1 of 21 CTCAE v4.0 Toxicity Codes Category ECOG Code CTCAE v4.0 Term Ear and labyrinth disorders AU999 Ear and labyrinth disorders - Other, specify Ear and labyrinth disorders AU101 Ear pain Ear and labyrinth disorders AU102 External ear inflammation Ear and labyrinth disorders AU103 External ear pain Ear and labyrinth disorders AU104 Hearing impaired Ear and labyrinth disorders AU105 Middle ear inflammation Ear and labyrinth disorders AU106 Tinnitus Ear and labyrinth disorders AU107 Vertigo Ear and labyrinth disorders AU108 Vestibular disorder Endocrine disorders EN101 Adrenal insufficiency Endocrine disorders EN102 Cushingoid Endocrine disorders EN103 Delayed puberty Endocrine disorders EN999 Endocrine disorders - Other, specify Endocrine disorders EN104 Growth accelerated Endocrine disorders EN105 Hyperparathyroidism Endocrine disorders EN106 Hyperthyroidism Endocrine disorders EN107 Hypoparathyroidism Endocrine disorders EN108 Hypothyroidism Endocrine disorders EN109 Precocious puberty Endocrine disorders EN110 Virilization Eye disorders OC101 Blurred vision Eye disorders OC102 Cataract Eye disorders OC103 Conjunctivitis Eye disorders OC104 Corneal ulcer Eye disorders OC105 Dry eye Eye disorders OC106 Extraocular muscle paresis Eye disorders OC999 Eye disorders - Other, specify Eye disorders OC107 Eye pain Eye disorders OC108 Eyelid function disorder Eye disorders OC109 Flashing lights Eye disorders OC110 Floaters Eye disorders OC111 Glaucoma Eye disorders OC112 Keratitis Eye disorders OC113 Night blindness Eye disorders OC114 Optic nerve disorder Eye disorders OC115 Papilledema Eye disorders OC116 Photophobia Eye disorders OC117 Retinal detachment Eye disorders OC118 Retinal tear Eye disorders OC119 Retinal vascular disorder Eye disorders OC120 Retinopathy Eye disorders OC121 Scleral disorder Eye disorders OC122 Uveitis Eye disorders OC123 Vitreous hemorrhage Eye disorders OC124 Watering eyes Gastrointestinal disorders GI101 Abdominal distension Gastrointestinal disorders GI102 Abdominal pain Gastrointestinal disorders GI103 Anal fistula Page 2 of 21 CTCAE v4.0 Toxicity Codes Category ECOG Code CTCAE v4.0 Term Gastrointestinal disorders GI104 Anal hemorrhage Gastrointestinal disorders GI105 Anal mucositis Gastrointestinal disorders GI106 Anal necrosis Gastrointestinal disorders GI107 Anal pain Gastrointestinal disorders GI108 Anal stenosis Gastrointestinal disorders GI109 Anal ulcer Gastrointestinal disorders GI110 Ascites Gastrointestinal disorders GI111 Bloating Gastrointestinal disorders GI112 Cecal hemorrhage Gastrointestinal disorders GI113 Cheilitis Gastrointestinal disorders GI114 Colitis Gastrointestinal disorders GI115 Colonic fistula Gastrointestinal disorders GI116 Colonic hemorrhage Gastrointestinal disorders GI117 Colonic obstruction Gastrointestinal disorders GI118 Colonic perforation Gastrointestinal disorders GI119 Colonic stenosis Gastrointestinal disorders GI120 Colonic ulcer Gastrointestinal disorders GI121 Constipation Gastrointestinal disorders GI122 Dental caries Gastrointestinal disorders GI123 Diarrhea Gastrointestinal disorders GI124 Dry mouth Gastrointestinal disorders GI125 Duodenal fistula Gastrointestinal disorders GI126 Duodenal hemorrhage Gastrointestinal disorders GI127 Duodenal obstruction Gastrointestinal disorders GI128 Duodenal perforation Gastrointestinal disorders GI129 Duodenal stenosis Gastrointestinal disorders GI130 Duodenal ulcer Gastrointestinal disorders GI131 Dyspepsia Gastrointestinal disorders GI132 Dysphagia Gastrointestinal disorders GI133 Enterocolitis Gastrointestinal disorders GI134 Enterovesical fistula Gastrointestinal disorders GI135 Esophageal fistula Gastrointestinal disorders GI136 Esophageal hemorrhage Gastrointestinal disorders GI137 Esophageal necrosis Gastrointestinal disorders GI138 Esophageal obstruction Gastrointestinal disorders GI139 Esophageal pain Gastrointestinal disorders GI140 Esophageal perforation Gastrointestinal disorders GI141 Esophageal stenosis Gastrointestinal disorders GI142 Esophageal ulcer Gastrointestinal disorders GI143 Esophageal varices hemorrhage Gastrointestinal disorders GI144 Esophagitis Gastrointestinal disorders GI145 Fecal incontinence Gastrointestinal disorders GI146 Flatulence Gastrointestinal disorders GI147 Gastric fistula Gastrointestinal disorders GI148 Gastric hemorrhage Gastrointestinal disorders GI149 Gastric necrosis Gastrointestinal disorders GI150 Gastric perforation Gastrointestinal disorders GI151 Gastric stenosis Page 3 of 21 CTCAE v4.0 Toxicity Codes Category ECOG Code CTCAE v4.0 Term Gastrointestinal disorders GI152 Gastric ulcer Gastrointestinal disorders GI153 Gastritis Gastrointestinal disorders GI154 Gastroesophageal reflux disease Gastrointestinal disorders GI999 Gastrointestinal disorders - Other, specify Gastrointestinal disorders GI155 Gastrointestinal fistula Gastrointestinal disorders GI156 Gastrointestinal pain Gastrointestinal disorders GI157 Gastroparesis Gastrointestinal disorders GI158 Gingival pain Gastrointestinal disorders GI159 Hemorrhoidal hemorrhage Gastrointestinal disorders GI160 Hemorrhoids Gastrointestinal disorders GI161 Ileal fistula Gastrointestinal disorders GI162 Ileal hemorrhage Gastrointestinal disorders GI163 Ileal obstruction Gastrointestinal disorders GI164 Ileal perforation Gastrointestinal disorders GI165 Ileal stenosis Gastrointestinal disorders GI166 Ileal ulcer Gastrointestinal disorders GI167 Ileus Gastrointestinal disorders GI168 Intra-abdominal hemorrhage Gastrointestinal disorders GI169 Jejunal fistula Gastrointestinal disorders GI170 Jejunal hemorrhage Gastrointestinal disorders GI171 Jejunal obstruction Gastrointestinal disorders GI172 Jejunal perforation Gastrointestinal disorders GI173 Jejunal stenosis Gastrointestinal disorders GI174 Jejunal ulcer Gastrointestinal disorders GI175 Lip pain Gastrointestinal disorders GI176 Lower gastrointestinal hemorrhage Gastrointestinal disorders GI177 Malabsorption Gastrointestinal disorders GI178 Mucositis oral Gastrointestinal disorders GI179 Nausea Gastrointestinal disorders GI180 Obstruction gastric Gastrointestinal disorders GI181 Oral cavity fistula Gastrointestinal disorders GI182 Oral dysesthesia Gastrointestinal disorders GI183 Oral hemorrhage Gastrointestinal disorders GI184 Oral pain Gastrointestinal disorders GI185 Pancreatic duct stenosis Gastrointestinal disorders GI186 Pancreatic fistula Gastrointestinal disorders GI187 Pancreatic hemorrhage Gastrointestinal disorders GI188 Pancreatic necrosis Gastrointestinal disorders GI189 Pancreatitis Gastrointestinal disorders GI190 Periodontal disease Gastrointestinal disorders GI191 Peritoneal necrosis Gastrointestinal disorders GI192 Proctitis Gastrointestinal disorders GI193 Rectal fistula Gastrointestinal disorders GI194 Rectal hemorrhage Gastrointestinal disorders GI195 Rectal mucositis Gastrointestinal disorders GI196 Rectal necrosis Gastrointestinal disorders GI197 Rectal obstruction Gastrointestinal disorders
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    Published OnlineFirst October 30, 2013; DOI: 10.1158/1078-0432.CCR-13-1840 Clinical Cancer Cancer Therapy: Clinical Research Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of Dalantercept, an Activin Receptor–like Kinase-1 Ligand Trap, in Patients with Advanced Cancer Johanna C. Bendell1, Michael S. Gordon2, Herbert I. Hurwitz3, Suzanne F. Jones1, David S. Mendelson2, Gerard C. Blobe3, Neeraj Agarwal4, Carolyn H. Condon5, Dawn Wilson5, Amelia E. Pearsall5, Yijun Yang5, Ty McClure5, Kenneth M. Attie5, Matthew L. Sherman5, and Sunil Sharma4 Abstract Purpose: The angiogenesis inhibitor dalantercept (formerly ACE-041) is a soluble form of activin receptor–like kinase-1 (ALK1) that prevents activation of endogenous ALK1 by bone morphogenetic protein-9 (BMP9) and BMP10 and exhibits antitumor activity in preclinical models. This first-in-human study of dalantercept evaluated its safety, tolerability, pharmacokinetics, pharmacodynamics, and antitu- mor activity in adults with advanced solid tumors. Experimental Design: Patients in dose-escalating cohorts received dalantercept subcutaneously at one of seven dose levels (0.1–4.8 mg/kg) every 3 weeks until disease progression. Patients in an expansion cohort received dalantercept at 0.8 or 1.6 mg/kg every 3 weeks until disease progression. Results: In 37 patients receiving dalantercept, the most common treatment-related adverse events were peripheral edema, fatigue, and anemia. Edema and fluid retention were dose-limiting toxicities and responded to diuretic therapy. No clinically significant, treatment-related hypertension, proteinuria, gross hemorrhage, or gastrointestinal perforations were observed. One patient with refractory squamous cell cancer of the head and neck had a partial response, and 13 patients had stable disease according to RECISTv1.1, eight of whom had prolonged periods (12 weeks) of stable disease.
  • 1 Surgical Pathology of the Mouth and Jaws R. A. Cawson, J. D. Langdon

    1 Surgical Pathology of the Mouth and Jaws R. A. Cawson, J. D. Langdon

    Surgical pathology of the mouth and jaws R. A. Cawson, J. D. Langdon, J. W. Eveson 12. Tumours of salivary glands A great variety of neoplasms can form in the salivary gland tissues. The classification of Thackray and Sobin (1972) (Table 12.1) is still widely used, but inevitably has been overtaken by the recognition of new types of tumours. A modified classification broadly based on changes proposed by the WHO Collaborating Center for Salivary Gland Tumors is therefore shown in Table 12.2, but even so it is not always easy to fit a particular tumour into one of these many categories. Non-neoplastic diseases have been discussed in the previous chapter, but in the parotid gland particularly it is not always possible to distinguish them from neoplasms preoperatively. Table 12.1 Classification of salivary gland tumours (After Thackray and Sobin, 1972) Epithelial A. Adenomas 1. Pleomorphic adenoma (mixed tumour) 2. Monomorphic adenoma (a) Adenolymphoma (Warthin's tumour) (b) Oxyphilic adenoma (oncocytoma) (c) Other monomorphic adenomas B. Mucoepidermoid tumour C. Acinic cell tumour D. Carcinomas 1. Adenoid cystic carcinoma 2. Adenocarcinoma 3. Squamous cell carcinoma 4. Undifferentiated carcinomas 5. Carcinoma in pleomorphic adenoma Non-Epithelial Haemangioma Lymphangioma Neurofibroma Lipoma Others including malignant varieties of the above Lymphoma. Age, site and sex distribution in relatin to tumour type In the British Salivary Gland Tumour Panel series of more than 3500 unselected tumours, there is a wide age distribution, but the peak incidence for benign tumours is in the sixth decade and, for malignant tumours, the seventh. Thus in the third decade, nearly 95% of tumours are benign, but by the seventh decade and after, 30% of tumours are malignant.